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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks are blue color, there-layer, flat-pleaded masks with nose piece and ear loops/ties, which are composed of outer layer, middle layer and inner layer. The outer layer and inner layer of the mask are made of polypropylene, the middle layer is made of melt-blown polypropylene. The ear loop/ties of the subject mask is held in place over the users' mouth and nose by two ear loops/ties welded to the face mask. The ear loop is made with polyester and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of high density polyethylene. The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100 Standard Specification for Performance of Materials Used in Surgical Face Masks.

The provided document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is categorized as a "Level 3 Barrier" surgical face mask.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.). It only indicates "Passed" for the results.

The data provenance is from non-clinical tests performed on the "Surgical Face Mask" manufactured by Xiantao Sanda Industrial Co., Ltd. The tests were conducted according to FDA guidance and international standards (ASTM, EN, ISO). The country of origin of the data is implied to be where the manufacturer is located or where the testing was contracted, which is China (Xiantao, Hubei). These are laboratory tests, not human data, so "retrospective or prospective" does not directly apply in the same way it would for clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the ground truth for device performance in this context is established by objective, standardized test methodologies and established acceptance criteria from recognized international standards (ASTM, EN, ISO) and FDA guidance documents. There are no human experts establishing ground truth for these physical and biological performance tests.

4. Adjudication Method for the Test Set

This section is not applicable. The "adjudication method" primarily refers to expert review processes for cases, which is relevant for clinical studies or image-based diagnostic AI. For non-clinical device performance tests like those described (e.g., filtration efficiency, breathability, flammability), the results are quantitative and objective, determined by the test procedures outlined in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in the context of AI assistance. This document describes a physical medical device (surgical face mask) with performance evaluated through non-clinical laboratory testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This section is not applicable. This document describes a physical surgical face mask, not an algorithm or AI-based device. The term "standalone performance" typically refers to the performance of an algorithm without human intervention, which does not apply here.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established scientific and engineering standards and their specified test methodologies. For example:

• Bacterial Filtration Efficiency (BFE): Measured according to ASTM F2101, using a biological aerosol of Staphylococcus Aureus. The "ground truth" is the empirically measured percentage of bacteria filtered.
• Differential Pressure: Measured according to EN 14683:2019 Annex C, the "ground truth" is the physical measurement of pressure drop across the mask.
• Sub-micron Particulate Filtration Efficiency (PFE): Measured according to ASTM F2299-17, using latex spheres. The "ground truth" is the empirically measured percentage of particles filtered.
• Resistance to Penetration by Synthetic Blood: Measured according to ASTM F1862-17. The "ground truth" is whether the synthetic blood penetrates the material at a specific pressure.
• Flammability: Assessed according to 16 CFR Part 1610-2008. The "ground truth" is the material's flammability classification.
• Biocompatibility: Evaluated according to ISO 10993 series (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Sensitization and Irritation). The "ground truth" is the biological response observed in standardized in vitro or in vivo tests.

These tests provide objective, measurable outcomes against predefined criteria.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The performance is assessed through direct physical and biological testing.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as point 8; there is no training set mentioned or implied for a physical medical device like a surgical face mask.

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